How might medical training be advantageous?
Susanne Ludgate of the MHRA states, ‘There are three major players in the device field: the industry, the regulator and, very importantly, the clinical user. Medical training provides an understanding of the environment in which that user works and the associated problems and issues… there is no doubt that a good grounding in the areas that regularly use devices is important both in offering advice to the Health Service and in a regulatory capacity.’ As a doctor you will have a fluency in medical terms and an ability to communicate with medical professionals. You will be able to understand the content of clinical trial reports. During your time as a medic you will have developed knowledge of the uses and limitations of a range of medical devices. Your clinical knowledge and understanding of the NHS will be important, as will your contacts in the field. In addition you might have experience of clinical trials and an understanding of the regulatory process.
Description of the roles and how to move into them
Working on any aspect of the regulation of a medical device. Work may include preparing submissions to the regulatory authorities, writing the product information and providing advice to other professionals on regulatory issues. You may also work directly for the MHRA. To build up experience, see if you can get some short-term contract experience with a device company in one area of the regulatory process such as pre-clinical summary writing. (For more tips see The Organisation for Professionals in Regulatory Affairs (TOPRA) website).
Monitoring the manufacturing process and analysing associated data. Ensuring that the device complies with industry standards and legal requirements such as the ISO 13485 standard. Gaining experience of clinical audit will show an interest in quality improvement systems. Quality assurance professionals sometimes move over into regulatory affairs. In both of these areas, medical experience of what makes a device fit for purpose for the user will be relevant.
Sales and marketing:
In sales you will be liaising with GPs and hospital staff to sell, promote and raise awareness of new devices. You will be setting up meetings, giving presentations, persuading professionals of the suitability of your product. In marketing you will be launching products, writing copy, researching the market and competitors. As a medic moving into sales and marketing you will have an understanding of the language and attitudes of your clients. Your understanding of physiology and medical science will make it easier to understand the application of the product. Your medical contacts will be useful. Developing core sales skills centre around persuasion and resilience, would be useful.
Working as a clinical research associate (CRA) you will be involved in setting up and running clinical trials which might include writing protocols, setting up study centres, monitoring the trial and dealing with the regulatory authority. You could work for a Contract Research Organisation (CRO) which specialises in medical devices, or for a subsection of a pharmaceutical company. There is a clear career ladder with levels of responsibility increasing with experience. The experience required varies, for example an advertisement for a Clinical Research Associate asks for ‘an understanding of the diabetes care customer base, an understanding of diabetes and its treatment… and an understanding of good clinical practice’. These are all things you may have picked up on rotation or through your chosen specialty. Getting involved in clinical trials as a medic will provide you with some relevant experience, as will moving into a hospital-based post as a research fellow.
Research and Development:
This is the starting point of the process of bringing a medical device to market. You may be involved in coming up with a concept for a device, through to designing and testing components and prototypes. Doing a PhD in a relevant subject is a good starting point but not always essential. An academic in the field described a clinician’s perspective on what will work as ‘vitally necessary’ in the research process. This is backed up by a report from the Health Industry Task Force calling for greater collaboration between the Health Service and academia.
Training routes/relevant courses
Susanne Ludgate from the MHRA notes ‘There are very few supportive courses on medical devices. The course at Cranfield on regulatory affairs is highly regarded and many of the device staff at MHRA lecture there. This is secondary however to building on a wide medical background. For more information on the course see www.cranfield.ac.uk/students/courses/
. TOPRA also run an MSc in regulatory affairs www.topra.org/postgraduate-qualifications
Sales and Marketing:
For sales roles you will receive training in sales and the products when you start the job and you will also be required to take the ABPI sales examinations. The Chartered Institute of Marketing runs courses at various levels see www.cim.co.uk as does the Institute of Sales and Marketing Management www.ismm.co.uk/
Clinical Trials: There are Masters courses run by Cranfield, Liverpool John Moores, Glamorgan and Surrey. The London School of Hygiene runs a distance learning course in clinical trials. The Institute of Clinical Research runs e-learning modules.
Research and development: Search for relevant PhD or research positions on www.jobs.ac.uk or www.findaphd.co.uk .